The OncFive: Top Oncology Articles for the Week of 1/19

Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.

Here’s what you may have missed this week:

FDA Approves Treosulfan for allHCT Conditioning in AML and MDS

This week, the regulatory agency greenlit treosulfan (Grafapex) paired with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients at least 1 year of age with acute myeloid leukemia or myelodysplastic syndrome. The decision was based on data from the phase 3 MC-FludT.14/L trial (NCT00822393). “The FDA approval provides a useful option for adult and pediatric patients, with the potential to enhance overall survival while minimizing adverse effects,” Filippo Milano, MD, PhD, of Fred Hutch Cancer Center, stated in a news release.

RP1 Plus Nivolumab Snags Priority Review for Select Advanced Melanoma

The regulatory agency also accepted and granted priority review to a biologics license application (BLA) seeking the approval of RP1 (vusolimogene oderparepvec) plus nivolumab (Opdivo) for use in adult patients with advanced melanoma who have previously received a PD-1–containing regimen. The BLA is based on data from the phase 1/2 IGNYTE trial (NCT03767348) shared at the 2024 SITC Annual Meeting and was assigned a target action date of July 22, 2025, under the Prescription Drug User Fee Act. “We look forward to working closely with the FDA on the review of our application,” Sushil Patel, PhD, of Replimune, stated in a news release.

Oncology Experts Preview Top Abstracts to be Shared at 2025 ASCO GI

EXCLUSIVE CONTENT: Ahead of this year’s Gastrointestinal Cancers Symposium, OncLive asked Ad Board members and experts in the space, Tanios S. Bekaii-Saab, MD, of Mayo Clinic, and Yelena Y. Janjigian, MD, of Memorial Sloan Kettering Cancer Center, about which presentations they are most excited to learn more about and why. The abstract that made both of their lists? LBA143, which details the first results from the phase 3 CheckMate-8HW trial (NCT04008030), which is examining nivolumab (Opdivo) plus ipilimumab (Yervoy) vs single-agent nivolumab in patients with microsatellite instability–high/mismatch repair–deficient metastatic colorectal cancer.

Felix Y. Feng, MD, Leading Radiation Oncologist and Genitourinary Cancer Researcher, Dies at 48

Felix Y. Feng, MD, died of cancer on December 10, 2024; he was 48 years old. Feng was the vice chair for translational research in the Department of Radiation Oncology, and the George Judy Marcus Distinguished Professor, director of the Benioff Initiative for Prostate Cancer Research, and professor of Radiation Oncology, Urology, and Medicine at the University of California San Francisco (UCSF). “[He] was an exceptional scientist—a once-in-a-generation scientist—and his staggering intellect and scientific insights led to his remarkable scientific accomplishments,” Eric J. Small, MD, of UCSF Helen Diller Family Comprehensive Cancer Center, stated in a news release.

AVA6000 Elicits Clinically Meaningful Tumor Shrinkage in Salivary Gland Cancer

The peptide drug conjugate consisting of doxorubicin, when given at a dose of 250 mg/m² or higher, led to clinically meaningful tumor shrinkage in 5 of 10 patients with fibroblast activation protein-alpha–positive salivary gland cancer enrolled in a phase 1a trial (NCT04969835). One patient achieved a confirmed partial response, and 4 patients experienced minor responses by RECIST v1.1 criteria. “These data highlight the transformative potential of our precision peptide drug conjugates in expanding the efficacy of highly potent therapeutics and support our growing optimism in this program,” Christina Coughlin, MD, PhD, of Avacta Therapeutics, stated in a news release.